Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in labeling: Hypotension [see Warnings and Precautions (5.2)] Renal Impairment [see Warnings and Precautions (5.3)] Electrolytes and Metabolic Disorders [see Warnings and Precautions (5.4)] The most common adverse reactions (≥2% of patients) were upper respiratory tract infection, dizziness, sinusitis, diarrhea, fatigue, influenza-like symptoms, and nausea (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995- 4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Telmisartan and hydrochlorothiazide has been evaluated for safety in more than 1700 patients, including 716 treated for hypertension for longer than 6 months and 420 for more than 1 year.
Adverse reactions have been limited to those that have been previously reported with telmisartan and/or hydrochlorothiazide.
Adverse reactions occurring at an incidence of ≥2% in patients treated with telmisartan/hydrochlorothiazide and at a greater rate than in patients treated with placebo, are presented in Table 1 [see Clinical Studies (14)].
Table 1 Adverse Reactions Occurring at an Incidence of ≥2% in Patients Treated with Telmisartan/Hydrochlorothiazide and at a Greater Rate Than in Patients Treated with Placebo* Telmisartan/ Hydrochlorothiazide (n = 414) Placebo (n = 74) Telmisartan (n = 209) Hydrochlorothiazide (n = 121) Body as a whole Fatigue 3% 1% 3% 3% Influenza-like symptoms 2% 1% 2% 3% Central/Peripheral nervous system Dizziness 5% 1% 4% 6% Gastrointestinal system Diarrhea 3% 0% 5% 2% Nausea 2% 0% 1% 2% Respiratory system disorder Sinusitis 4% 3% 3% 6% Upper respiratory tract infection 8% 7% 7% 10% * includes all doses of telmisartan (20 to 160 mg), hydrochlorothiazide (6.25 to 25 mg), and combinations thereof Other adverse reactions observed for telmisartan/hydrochlorothiazide were: pain (including back and abdominal), dyspepsia, erythema, vomiting, bronchitis, and pharyngitis.
Adverse reactions occurred at approximately the same rates in men and women, older and younger patients, and black and non-black patients.
Telmisartan Other adverse events that have been reported with telmisartan are listed below: Autonomic Nervous System: impotence, increased sweating, flushing Body as a Whole: allergy, fever, leg pain, chest pain Cardiovascular: palpitation, angina pectoris, abnormal ECG, hypertension, peripheral edema Central Nervous System: insomnia, somnolence, migraine, paresthesia, involuntary muscle contractions, hypoesthesia Gastrointestinal: flatulence, constipation, gastritis, dry mouth, hemorrhoids, gastroesophageal reflux, toothache Hepato-biliary: elevations of liver enzymes or serum bilirubin Metabolic: gout, hypercholesterolemia, diabetes mellitus Musculoskeletal: arthritis, arthralgia, leg cramps, myalgia Psychiatric: anxiety, depression, nervousness Resistance Mechanism: infection, abscess, otitis media Respiratory: asthma, rhinitis, dyspnea, epistaxis Skin: dermatitis, eczema, pruritus Urinary: micturition frequency, cystitis Vascular: cerebrovascular disorder Special Senses: abnormal vision, conjunctivitis, tinnitus, earache Hydrochlorothiazide Other adverse events that have been reported with hydrochlorothiazide are listed below: Body as a Whole: weakness Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions Metabolic: hyperglycemia, glycosuria Musculoskeletal: muscle spasm Nervous System/Psychiatric: restlessness Renal: interstitial nephritis Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis Special Senses: transient blurred vision, xanthopsia Clinical Laboratory Findings Creatinine, Blood Urea Nitrogen (BUN) : Increases in BUN (≥11.2 mg/dL) and serum creatinine (≥0.5 mg/dL) were observed in 2.8% and 1.4%, respectively, of patients with essential hypertension treated with telmisartan and hydrochlorothiazide tablets in controlled trials.
No patient discontinued treatment with telmisartan and hydrochlorothiazide tablets because of an increase in BUN or creatinine [see Warnings and Precautions (5.3)] .
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of telmisartan and hydrochlorothiazide.
5 WARNINGS AND PRECAUTIONS Avoid fetal or neonatal exposure (5.1) Correct volume or salt depletion before initiating therapy.
Observe for signs and symptoms of hypotension (5.2) Monitor renal function and potassium in susceptible patients (5.3) Observe for clinical signs of fluid or electrolyte imbalance (5.4) Hypersensitivity Reaction (5.5) Acute Myopia and Secondary Angle-Closure Glaucoma (5.6) 5.1 Fetal Toxicity Telmisartan Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death.
When pregnancy is detected, discontinue telmisartan and hydrochlorothiazide as soon as possible.
Like all medications, Telmisartan And Hydrochlorothiazide can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: